PPD has expanded its central lab testing services at its Brussels and Singapore labs and will offer additional services in microbiology, peripheral blood mononuclear cell and molecular pathology services.
Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.
Protalix Biotherapeutics is attempting to use its US FDA-approved Gaucher's disease treatment as a proof of concept and springboard for its plant-based cell manufacturing technology.
Bristol-Myers Squibb (B-MS) will continue to make the OTCs it licensed to Reckitt Benckiser for the time being but will hand over manufacturing if the UK drugmaker buys them outright.
Small biotech companies looking to crack into the increasingly lucrative Chinese pharma market need to outsource or partner with a local company in order to bring their products to market faster, experts said.
Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).
Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.
Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.
More flexible regulations on the path for approving potential Alzheimer's disease treatments represent a huge opportunity, according to the US FDA, CROs and research advocates.
The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.
An Indian export group has published what it claims are draft CDSCO guidelines setting out what API makers must do to comply with EU import rules that come into effect this summer.
In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company downplayed the impact of the letter and said it won’t create...
CROs invest in scope and scale while private-equity groups buy firms they can expand according to Fairmount Partners’ managing director, Neal McCarthy.
The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to comply,...
A storm is brewing over the release of clinical trial data as GlaxoSmithKline on Tuesday took a step away from UK and US industry groups and said it intends to publish clinical study reports for all approved medicines dating back to when the company was...
Clinical trials made public by Pfizer did not match internal reports or reflect what was done in studies of the seizure drug gabapentin say researchers calling for revision of journal publishing codes.
Icon has agreed to purchase the clinical trials services division of Cross Country Healthcare for $52m to primarily expand its staffing, pharmacovigilance and drug safety services.
The US pharma industry in 2012 saw the lowest number of reported cargo thefts and the lowest average value per incident since the data collection began in 1996.
Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).
Clinical trial inspectors are being called on by the European Medicines Agency (EMA) to focus their efforts more on findings that are likely to impact the benefit-risk evaluation of a drug.
Parexel may have raised its forecast for fiscal 2013 after reporting a 26% hike in second quarter revenues this week, but analysts still have concerns about its spending.
Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.
